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Clinical trials for Common Rule

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44363   clinical trials with a EudraCT protocol, of which   7387   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    21 result(s) found for: Common Rule. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-005442-23 Sponsor Protocol Number: 411-LY-08-01-0000 Start Date*: 2009-02-19
    Sponsor Name:Leyh Pharma GmbH
    Full Title: Evaluation of the efficacy and safety of nose spray containing 3% silver protein diacetyl tannate (SEAT) in patients with uncomplicated viral rhinitis. A placebo-controlled, randomized, multicentri...
    Medical condition: treatment of uncomplicated rhinal infections
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064948 Viral rhinitis LLT
    9.1 10066743 Acute rhinitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-002503-33 Sponsor Protocol Number: GC 2005 04 Start Date*: 2006-06-23
    Sponsor Name:Our Lady's Hospital for Sick Children
    Full Title: PROTOCOL FOR THE TREATMENT OF EXTRACRANIAL GERM CELL TUMOURS IN CHILDREN AND ADOLESCENTS (GC III)
    Medical condition: Extracranial germ cell tumours
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002385-23 Sponsor Protocol Number: AFT-MXCF-03 Start Date*: 2015-11-10
    Sponsor Name:AFT Pharmaceuticals Ltd
    Full Title: A phase 3 randomised, double blind, multiple dose, parallel group efficacy study of different doses of phenylephrine hydrochloride combined with paracetamol and/or ibuprofen in participants with na...
    Medical condition: nasal congestion
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028735 Nasal congestion PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-000421-39 Sponsor Protocol Number: AMLSG26-16/AML-ViVA Start Date*: 2017-02-03
    Sponsor Name:University Hospital Regensburg represented by Kaufmännischer Direktor
    Full Title: Randomized Phase II trial with safety run-in phase evaluating low-dose azacitidine, all-trans retinoic acid and pioglitazone versus standard dose azacitidine in patients >=60 years with acute myelo...
    Medical condition: acute myeloid leukemia refractory to standard induction chemotherapy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003889-39 Sponsor Protocol Number: NALPAC Start Date*: 2021-10-11
    Sponsor Name:Belgian Group of Digestive Oncology (BGDO)
    Full Title: A Non-Comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abra...
    Medical condition: Pancreatic ductal adenocarcinoma (PDAC)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004112-19 Sponsor Protocol Number: POLARIS2013-001 Start Date*: 2018-07-10
    Sponsor Name:Polaris Pharmaceuticals, Inc.
    Full Title: Phase 1-2 Study of ADI-PEG 20 plus FOLFOX in Subjects with Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma
    Medical condition: Advanced hepatocellular carcinoma (HCC)in the third line or later setting
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10049010 Carcinoma hepatocellular LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-004658-32 Sponsor Protocol Number: BGB-A317-A1217-203 Start Date*: 2021-06-03
    Sponsor Name:BeiGene, Ltd.
    Full Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody BGB-A...
    Medical condition: PD-L1 vCPS ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2010-022280-35 Sponsor Protocol Number: SSD113434 Start Date*: 2010-11-22
    Sponsor Name:GlaxoSmithKline
    Full Title: A randomised, double-blind, placebo-controlled study of topical GW870086X formulation in subjects with moderate or severe atopic dermatitis.
    Medical condition: subjects with moderate or severe atopic dermatitis.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003639 Atopic dermatitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002153-30 Sponsor Protocol Number: MO40628 Start Date*: 2018-10-24
    Sponsor Name:Roche Farma S.A.(Soc Uni) que realiza el ensayo en España y que actúa como representante de F. Hoffmann-La Roche Ltd.
    Full Title: A randomized, multicenter, open-label cross-over study to evaluate patient preference and satisfaction of subcutaneous administration of the fixed-dose combination of pertuzumab and trastuzumab in ...
    Medical condition: Human epidermal growth factor receptor 2 (HER2)-positive Early Breast Cancer.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) PT (Completed) SE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2020-005792-12 Sponsor Protocol Number: GOIRC-06-2020 Start Date*: 2022-04-05
    Sponsor Name:GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
    Full Title: Pilot ‘Window of Opportunity’ Neoadjuvant Study of Abemaciclib in Low-Estrogen Receptor (ER) positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative Early Breast Cancer (BC)
    Medical condition: Low-Estrogen Receptor (ER) positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative Early Breast Cancer (BC)
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083232 HER2 negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004875-38 Sponsor Protocol Number: PRIMEH&N Start Date*: 2020-11-12
    Sponsor Name:Fondazione GONO
    Full Title: The induction and maintenance treatment with PARP inhibitor and immunotherapy in HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC)
    Medical condition: HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10031112 Oropharyngeal squamous cell carcinoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10023856 Laryngeal squamous cell carcinoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066471 Squamous cell carcinoma of pharynx PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003248-63 Sponsor Protocol Number: QBGJ398-302 Start Date*: 2020-02-19
    Sponsor Name:QED Therapeutics, Inc.
    Full Title: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alt...
    Medical condition: Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10046731 Urothelial carcinoma urethra recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Completed) FR (Completed) BE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) IT (Prematurely Ended) BG (Prematurely Ended) PT (Prematurely Ended) GR (Completed)
    Trial results: View results
    EudraCT Number: 2009-010110-30 Sponsor Protocol Number: MK-0887A-087 Start Date*: 2016-03-15
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A phase III, randomized, active-controlled, parallel-group clinical trial to study the efficacy and long-term safety of mometasone furoate / formoterol fumarate (MF/F, MK-0887A [SCH418131]), compar...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) DK (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-002221-19 Sponsor Protocol Number: 2015_29 Start Date*: 2015-10-20
    Sponsor Name:CHRU of Lille
    Full Title: A Multicenter Open label Phase II study of Daratumumab in combination with dexamethasone in Multiple Myeloma resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide – an IFM 2014-04...
    Medical condition: Multiple Myeloma resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001489-17 Sponsor Protocol Number: SIOPENRNET003 Start Date*: 2006-11-17
    Sponsor Name:St. Anna Kinderkrebsforschung e.V.
    Full Title: High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)
    Medical condition: High Risk Neuroblastoma
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed) ES (Restarted) GB (GB - no longer in EU/EEA) BE (Completed) DK (Restarted) IT (Completed) IE (Completed) HU (Completed) FI (Completed) SI (Completed) PL (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004601-17 Sponsor Protocol Number: 1508-GCG Start Date*: 2017-06-19
    Sponsor Name:European Organisation For Research and Treatment of Cancer (EORTC)
    Full Title: A phase II study of the anti-PDL1 antibody atezolizumab, bevacizumab and acetylsalicylic acid to investigate safety and efficacy of this combination in recurrent platinum-resistant ovarian, fallopi...
    Medical condition: Ovarian neoplasms
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10051938 Ovarian adenocarcinoma LLT
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) FR (Completed) NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2019-004604-35 Sponsor Protocol Number: ICONMM Start Date*: 2020-06-17
    Sponsor Name:VU University Medical Center
    Full Title: A phase 2 study of CC220 (iberdomide) combined with low-dose cyclophosphamide and dexamethasone in relapsed/refractory multiple myeloma (IberCd): ICON study
    Medical condition: Relapsed/refractory multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004137-36 Sponsor Protocol Number: TIG-007 Start Date*: 2022-02-16
    Sponsor Name:iTeos Belgium SA
    Full Title: Study of EOS884448 alone, and in combination with iberdomide with or without dexamethasone, in participants with relapsed or refractory multiple myeloma
    Medical condition: Relapsed or refractory multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-004130-11 Sponsor Protocol Number: GEM21menos65 Start Date*: 2022-08-23
    Sponsor Name:FUNDACION PETHEMA
    Full Title: GEM21menos65. A Phase III trial for NDMM patients who are candidates for ASCT comparing Extended VRD plus Early Rescue Intervention vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D
    Medical condition: Newly-diagnosed multiple myeloma (NDMM) patients who are candidates for Autologous Stem Cell Transplant (ASCT).
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004851 10028229 Multiple myelomas HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003091-40 Sponsor Protocol Number: EMN26 Start Date*: 2020-12-04
    Sponsor Name: European Myeloma Network – EMN
    Full Title: PHASE II STUDY OF IBERDOMIDE (CC220) MAINTENANCE AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS
    Medical condition: Newly diagnosed multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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